ELECSYS PRECICONTROL UNIVERSAL

K090541 · Roche Diagnostics · JJY · Jul 2, 2009 · Clinical Chemistry

Device Facts

• Record ID: K090541
• Device Name: ELECSYS PRECICONTROL UNIVERSAL
• Applicant: Roche Diagnostics
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Elecsys PreciControl Universal is used for quality control of Elecsys immunoassays on the Elecsys and cobas e immunoassay analyzers. For Prescription Use Only

Device Story

Elecsys PreciControl Universal is a lyophilized, multi-analyte quality control material consisting of human serum matrix spiked with various antigens. It is designed for use on Elecsys and cobas e immunoassay analyzers to monitor the performance and accuracy of immunoassays. The product is reconstituted with distilled water by laboratory personnel and placed on the analyzer. The analyzer processes the control material alongside patient samples; the resulting values are compared against established ranges to verify system performance. This process ensures the reliability of clinical test results, aiding healthcare providers in diagnostic decision-making. The device is used in clinical laboratories by trained technicians.

Clinical Evidence

Bench testing only. Stability studies (accelerated and real-time) confirm shelf-life and open-vial stability. Target values assigned via comparison to master calibrators traceable to WHO/NIST standards. No clinical data required for this control material.

Technological Characteristics

Lyophilized human serum matrix; multi-analyte control; reconstituted with distilled water. Analyte concentrations are spiked during manufacture. Compatible with Elecsys and cobas e immunoassay analyzers. Storage: 2-8°C unopened; specific stability windows provided for reconstituted material at 20-25°C, 2-8°C, and -20°C.

Indications for Use

Indicated for quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers. No specific patient population or contraindications defined as this is an in vitro diagnostic control material.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Elecsys PreciControl Universal (K051687)

Submission Summary (Full Text)

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JUL - 2 2009

Elecsys PreciControl Universal

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K090541/

510(k) Summary – PreciControl Universal

| Introduction | According to the requirements of 21 CFR 807.92, the following information<br>provides sufficient detail to understand the basis for a determination of<br>substantial equivalence. |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter<br>name, address,<br>contact | Roche Diagnostics<br>9115 Hague Road<br>Indianapolis, IN 46250<br>317-521-3723<br>Contact Person: Gail Sauers<br>Date Prepared: February 27, 2009 |
| Submission<br>purpose | Roche Diagnostics hereby submits this Traditional 510(k) device<br>modification to provide notification of changes to our control material,<br>Elecsys PreciControl Universal (PCU).<br><br>PreciControl Universal is used for quality control of Elecsys immunoassays<br>on the Elecsys and cobas e immunoassay analyzers. This product contains<br>control material for numerous Elecsys assays in one convenient solution.<br><br>Changes to PCU consist of the addition of Carcinoembryonic antigen (CEA)<br>control and total (free + complexed) Prostate-Specific Antigen (PSA) to<br>extend the current functionality. |
| Device Name | Proprietary name: Elecsys PreciControl Universal.<br>Common name: PreciControl Universal<br>Classification name: Multi-Analyte Controls, All Kinds (assayed and<br>Unassayed) |
| Device<br>Description | The Elecsys PreciControl Universal is a lyophilized product consisting of<br>added antigens in a human serum matrix. During manufacture, the analytes<br>are spiked into the matrix at the desired concentration levels. |
| Intended use | Elecsys PreciControl Universal is used for quality control of Elecsys<br>immunoassays on the Elecsys and cobas e immunoassay analyzers. |
| | Continued on next page |
| Predicate<br>Device | The Elecsys PreciControl Universal is substantially equivalent to the<br>currently marketed Elecsys PreciControl Universal (PCU) K051687. |
| Device<br>Comparison | The table below indicates the similarities between the modified Elecsys<br>PreciControl Universal and the predicate PCU, K051687. |

Image /page/0/Picture/6 description: The image shows the word "Roche" inside of a hexagon with rounded corners. The word is written in a bold, sans-serif font. The hexagon is outlined in black, and the word "Roche" is also in black. The background of the image is white.

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# 510(k) Summary – continued

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### Similarities

| Characteristics | Elecsys PreciControl Universal | Predicate Device<br>Elecsys PreciControl Multianalyte<br>(K051687) |
|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Elecsys PreciControl Universal is used for<br>quality control of Elecsys<br>immunoassays on the<br>Elecsys and cobas e<br>immunoassay analyzers | Elecsys PreciControl<br>Universal is used for<br>quality control of the<br>Elecsys immunoassays<br>on Elecsys immunoassay<br>systems. |
| Reagent Format | Same | Lyophilized, based on<br>human serum in two<br>concentration ranges. |
| Matrix | Same | Human serum matrix |
| Stability | Same | Unopened:<br>Store at 2-8°C until<br>expiration date<br>Reconstituted (except<br>for Insulin):<br>• on the analyzers at 20-<br>25 °C: up to 5 hrs<br>• At 2-8°C: 3 days<br>• At -20°C: 1 month<br>(freeze only once)<br>Reconstituted for<br>Insulin:<br>• on the analyzers at 20-<br>25 °C: up to 5 hrs<br>• 20-25 °C: up to 5 hrs<br>• at -20: 1 month (freeze<br>only once) |

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Image /page/1/Picture/6 description: The image shows the Roche company logo. The logo consists of the word "Roche" written in a simple, sans-serif font. The word is enclosed within a hexagon shape, which provides a clear and defined border for the text.

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## 510(k) Summary - continued

| continued | Characteristics | Elecsys PreciControl<br>Universal | Predicate Device<br>Elecsys PreciControl<br>Multianalyte<br>(K051687) |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | Handling | Same | Reconstitute with<br>exactly 3.0 mL of<br>distilled water and allow<br>to stand closed for 30<br>minutes to reconstitute,<br>and then mix gently. |
| Performance | | The Elecsys PreciControl Universal was evaluated for value assignment and | |
| | stability. | | |
| | | The table below indicates the differences between the modified Elecsys<br>PreciControl Universal and the predicate PCU, K051687. | |
| Characteristics<br>Device<br>Comparison<br>Differences | Characteristics | Elecsys PreciControl<br>Universal | Predicate Device<br>Elecsys PreciControl<br>Multianalvte<br>(K051687) |
| Differences -<br>continued | Characteristics | Elecsys PreciControl<br>Universal | Predicate Device Elecsys<br>PreciControl<br>Multianalyte<br>(K051687) |
| Analyte<br>Concentration | • AFP (human cell culture) approx. 10-50 IU/ml | • AFP (human cell culture) approx. 10-50 IU/ml | |
| | • Cortisol (vegetable) approx. 359-500 nmol/L | • B12 (synthetic) approx. 1-.5 ng/mL | |
| | • DHEAs (synthetic) approx. 200-500 µg/dL | • Cortisol (vegetable) approx. 13-30 µg/dL | |
| | • Estradiol (synthetic) approx. 100-500 pg/mL | • DHEAs (synthetic) approx. 200-500 µg/dL | |
| | • FSH (human) approx. 10-45 mIU/mL | • Estradiol (synthetic) approx. 100-500 pg/mL | |
| | • fT3 (synthetic) approx. 6-25 pmol/L | • Ferritin (human) approx. 150-30 ng/mL | |
| | • fT4 (synthetic) approx. 12-35 pmol/L | • Folate (synthetic) approx. 12-5.5 ng/mL | |
| | • hCG (human) approx. 5-40 mIU/mL | • FSH (human) approx. 10-45 mU/mL | |
| | • IgE (human) approx. 70-300 U/mL | • fT3 (synthetic) approx. 4-16 pg/mL | |
| | • Insulin, (human, recomb.) approx. 25-80 μU/mL | • fT4 (synthetic) approx. .9-2.7 ng/dL | |
| | • LH (human) approx. 9-50 mIU/mL | • hCG (human) approx. 10-40 mU/mL | |
| | • Progesterone (vegetable) approx. 8-20 ng/mL | • IgE (human) approx. 70-300 U/mL | |
| | • Prolactin (human recombinant) approx. 233-848 µIU/mL | • Insulin, (human, recomb.) approx. 25-80 μU/mL | |
| | • SHBG (human) endogenous | • LH (human) approx. 9-50 mU/mL | |
| | • T3 (synthetic) approx. 2-6 nmol/mL | • Progesterone (vegetable) approx. 8-20 ng/mL | |
| | • T4 (synthetic) approx. 90-170 nmol/L | • Prolactin (human recombinant) approx. 11-40 ng/mL | |
| | • Testosterone (vegetable) approx. 6-2.5 ng/mL | • SHBG (human) endogenous | |
| | • Thyroglobulin * (human) approx. 25-100 ng/mL | • T3 (synthetic) approx. 1.5-4 ng/mL | |
| | • TSH (human) approx. 1-8.5 µIU/mL<br>• T-Uptake approx. (human) 1-.75 TBI<br>• CEA (human cell culture) approx. 5-50 ng/mL<br>• tPSA (human) approx. 1-40 ng/mL<br>• S100 * (bovine) approx. .2-2.5 ng/mL<br>* not included in US labeling | • T4 (synthetic) approx. 7-13 µg/dL<br>• Testosterone (vegetable) approx. 6-2.5 ng/mL<br>• TSH (human) 1-8.5 µU/mL<br>• T-Uptake (human) 1.1-.75 TBI | |

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### Elecsys PreciControl Universal

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Image /page/4/Picture/9 description: The image shows the word "Roche" inside of a hexagon. The word is written in a simple, sans-serif font. The hexagon is outlined in black, and the word "Roche" is also in black. The background of the image is white.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Roche Diagnostics ATTN: Ms. Gail Sauers Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250-0416

JUL - 2 2009

k090541 Re:

> Trade/Device Name: Elecsys PreciControl Universal Regulation Number: 21 CFR §862,1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I (Reserved) Product Code: JJY Dated: May 27, 2009 Received: June 02, 2009

Dear Ms. Sauers:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or ( 301 ) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

CA

Courtney C. Harper, Ph.D. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Indication for Use

510(k) Number (if known):

Device Name: Elecsys PreciControl Universal

Indication For Use:

Elecsys PreciControl Universal is used for quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

Prescription Use _ X (21 CFR Part 801 Subpart D) . And/Or

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Division Sign-Off

notir

Office of In Vitro Diagnostic Device Evaluation and Safety

Evaluation and Safety:
510(k) K096541

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